Why Haven't Government Officials Notified Individuals
Who Received Tainted Blood?
March 1, 1999
It seems hard to imagine,
but it's true. A new congressional report states that
more than one million Americans received blood from
donors who subsequently tested positive for hepatitis
C. Yet most of the recipients don't know that, and no
one is notifying them.
On October 8, 1998,
the House Committee on Government Reform and Oversight
released a report, "Hepatitis C:
Silent Epidemic, Mute Public Health Response," that
criticizes the Department of Health and Human Services
(HHS) for failing to respond to the hepatitis C epidemic.
It explains that the disease has now spread to an estimated
4 million Americans. The report also notes that the
total societal cost is more than $600 million per year.
FDA Has Known for Years
What's most disturbing
about the report is that it acknowledges that the Food
and Drug Administration (FDA), which regulates the blood
banking industry, has known about the tainted blood
situation since at least 1989, but hasn't informed patients.
According to the report,
FDA officials met on seven different occasions between
1989 and 1994 to decide whether to notify the blood
recipients. (The report notes that the hepatitis C virus
was first unmasked in 1989.) The FDA refrained from
recommending notification because "no clear consensus
on the public health benefit of such action had emerged."
Yet, treatment options were available to infected persons
if they had been told of their infection, according
to the report.
Additionally, at a September
9, 1998 Congressional hearing, the FDA's Dr. Jay Epstein
reported that the blood banks informed FDA that notification
letters had been sent to recipients. However, Dr. Epstein
acknowledged that the FDA had no independent verification
that this had occurred and was simply relying on the
blood banks' unwritten assurances, according to the
Another FDA witness,
Dr. Michael Friedman, admitted that no recipient of
hepatitis C-infected blood products had yet received
a letter about possible infection, the report says.
Notification Recommended, But Not Required
Congress began holding
hearings about the blood-related hepatitis C epidemic
in 1995, years after individuals received the tainted
blood. At that time, the House Committee on Government
Reform and Oversight recommended that HHS establish
a comprehensive program to notify the recipients. But
as we now know, that didn't happen.
Instead, the FDA issued
guidelines merely recommending that blood banks notify
them. No one is being held responsible for this, however.
That is disturbing because according to the Centers
for Disease Control (CDC), hepatitis can linger without
symptoms for more than 20 years, then produce profound
health consequences, including liver failure and cancer.
What If Alternative Providers Had Done It?
What do you think would
have happened if alternative providers or vitamin manufacturers
unknowingly sold a product that infected Americans with
a deadly disease?
The FDA would have put
those providers out of business! Those providers would
probably be locked up for years, fined thousands of
dollars, and be forced to notify all recipients of their
However, the medical
industry is not being held accountable for directly
notifying all recipients of tainted blood, nor is the
government helping in a truly effective way. Moreover,
it appears that public health officials are allowing
individuals to unknowingly spread hepatitis C.
What's going to happen
next? Will the CDC soon recommend, and then states mandate,
that all children must be vaccinated against hepatitis
C, like they're currently doing for hepatitis B?
At Least 300,000 Infected
The CDC estimates that
approximately 300,000 people have contracted hepatitis
C from infected blood since 1990. According to the Congressional
report, the first test for the hepatitis C virus became
available in 1990. A second, more accurate test was
introduced in 1992. CDC provides an estimate for the
number of transmissions after 1990, and not before.
CDC claims that "it
is not possible to estimate the TOTAL number of living
persons with transfusion-associated HCV [hepatitis C
virus] infection from the look back estimates, since
these estimates do not extend before 1990."
Out of the 4 million
persons living with hepatitis C, the government is not
exactly sure how many contracted their disease from
tainted blood before 1990.
Protect Yourself and Your Family
If you or a loved one
is to receive blood or blood products, you should inquire
about the chances of its being tainted. Don't be surprised
to hear a response such as, "Oh, don't worry. We test
blood for everything today." Even so, get your assurances
in writing when you sign your informed-consent form
(giving permission for surgery and the blood transfusion).
You might also want
to ask your blood bank and hospital for assurance that
you will be notified of any "look back" discoveries
that you received a tainted blood transfusion.
If you've received blood
over the past few decades, contact your doctor, hospital,
or local blood bank to find out whether you could have
contracted hepatitis C. Be prepared for the friction
you might encounter for doing your own investigation.
It is obvious we can't
count on HHS, FDA, or CDC to guarantee notification,
so take the responsibility for yourself. It's your
life you're protecting!
Note: This information is not intended as medical
advice. Consult a physician regarding your chances of
contracting hepatitis C through blood or blood products.
This article originally appeared in the January/February
1999 issue of Health